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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074069
Company: AMNEAL

Products on ANDA 074069

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	AB	No	No
AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	AB	No	No
AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074069

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/25/2017	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/19/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/21/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/23/2008	SUPPL-4	Labeling		Label is not available on this site.
02/01/2007	SUPPL-3	Labeling		Label is not available on this site.
06/22/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074069

AZATHIOPRINE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZASAN	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	075252	AAIPHARMA LLC
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	208687	ALKEM LABS LTD
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	074069	AMNEAL
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	075568	RISING
AZATHIOPRINE	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	No	AB	077621	ZYDUS PHARMS USA
IMURAN	AZATHIOPRINE	50MG	TABLET;ORAL	Prescription	Yes	AB	016324	SEBELA IRELAND LTD

TABLET;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZASAN	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	No	AB	075252	AAIPHARMA LLC
AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	No	AB	208687	ALKEM LABS LTD
AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	No	AB	074069	AMNEAL
AZATHIOPRINE	AZATHIOPRINE	75MG	TABLET;ORAL	Prescription	No	AB	077621	ZYDUS PHARMS USA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZASAN	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	No	AB	075252	AAIPHARMA LLC
AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	No	AB	208687	ALKEM LABS LTD
AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	No	AB	074069	AMNEAL
AZATHIOPRINE	AZATHIOPRINE	100MG	TABLET;ORAL	Prescription	No	AB	077621	ZYDUS PHARMS USA

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